Journal of Indian Academy of Oral Medicine and Radiology

: 2009  |  Volume : 21  |  Issue : 3  |  Page : 105--106

Clinical drug trials in oral medicine

Asif Shaik 
 Department of Oral Medicine and Radiology, Sri Sai College of Dental Surgery, Vikarabad, India

Correspondence Address:
Asif Shaik
Sri Sai College of Dental Surgery, Opp. Shiva Sagar, Kothrapally, Vikarabad, Ranga Reddy

How to cite this article:
Shaik A. Clinical drug trials in oral medicine.J Indian Acad Oral Med Radiol 2009;21:105-106

How to cite this URL:
Shaik A. Clinical drug trials in oral medicine. J Indian Acad Oral Med Radiol [serial online] 2009 [cited 2023 Feb 4 ];21:105-106
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Full Text

For a doctor, the magical tool that satisfies the patient suffering is the drug. For this magical tool to show the miracle of healing, it has to undergo a series of clinical trials as "the toughest iron goes through the hottest fire".

It is interesting to know that this wisdom of proving the safety of a drug and the need to conduct a clinical trial dates back to 1025 AD by AVICENNA who laid down rules for the experimental use of a drug. [1] To quote a few, the drug must be free from any extraneous space activity; it must be used on simple disease; the time of action must be observed. The quality of drug must correspond to the strength of the disease and the effect of the drug must seem to occur constantly.

The era of clinical research remembers James Lind for his extensive work in the treatment of scurvy with the use of citrus fruits. Since the time of James Lind to the era of modern technology, many trials have been conducted to know the efficacy of the drug.

A clinical drug trial can be defined as any form of planned experiment which involves a subject and is designed to elucidate the most appropriate treatment for the patient under a given medical condition. [2] Clinical drug trial can be seen as an application of scientific method for understanding the nature of the drug and its affect on the human mankind.

One way of classifying clinical trial is the way the study is carried out: [3]

An observational study, wherein the clinician observe the subjectsAn interventional study, wherein the investigator gives the research subject the particular medicine Another way of classifying clinical trial is their purpose. This includes preventional trial, screening trial, diagnostic trial, and compassionate use of trial. [3]

The research team comprises the clinician, sponsor, the patient, and ethical committee who approves the study. Prior to the main study, many pre clinical trials are conducted (in vitro-test tube and in vivo-experimental animals) to know the primary efficacy, the pharmacokinetics and the adverse effect of the drug. [2] In co ordination with the sponsor, the clinician gains the approval from the ethical committee by explaining the need of the study. During the procedure, the clinician recruits the patient with pre determined character, administers the drug and collects the data of the patient at a definite time period. The subjects willing to participate in the study are instructed to sign the document called the "informed Consent". It is a legally defined process of a person being told about the key facts involved in a clinical trial before deciding whether or not to participate in the study. [3] Initially, a pilot study is conducted in micro dose i.e. single ascending dose (S.A.D) to evaluate the safety of the drug, later multiple ascending dose (M.A.D) are given to the subject to assess the tolerability, pharmacokinetics and the dynamic of the drug. This entire procedure is carried out under the supervision of a certified observer.

If the research on a specific drug is performed in different parts of the world, a "clinical protocol" has to be carried out by the team members. It is an operating manual which ensures the clinician to perform the trial in the same way on patients with the same character.

The trial is performed on larger population to asses how well the drug is used. The team comprises random control trial (RCT) which conducts study on large population aimed at being the definitive assessment of how effective the drug is and its comparison with the current gold standard treatment. In a clinical trial, one must not forget about the safety of the subject which is a share between the sponsor, the local side investigator, the people who supervise the study and the regulatory agency by the country where the drug will be sold.

Dentistry has been slow to embrace oral medicine as a specialist discipline. Many would regard oral medicine as not a special branch of medicine, but the whole of medicine looked at from a special point of view, namely through mouth. The dental students consider only conditions in the mouth and doctors ignored this part of the body as out side their province, and dentistry did not always benefit from the enormous advances or specific medicine. It was Sir Johathan Hutchison (1828-1880) surgeon to the London hospital who must be regarded as the father of oral medicine as he was the first to describe a number of conditions of great interest to those working in the field of oral medicine.

The most commonly used drugs in oral medicine are not available to us by chance but have gone through different stages of clinical trials which are been used safely today on the patient. Some drugs which have passed on clinical trial have been banned by different nations around the world as they have shown long-term side effect on human race-(Rofecoxib and Nimesulide). The period of mother hood is the gift for the women, so they have to be dealt with an out most care during prescription of any drug. Thanks to the clinical trials which had led a helping hand in identifying the teratogenic effect of these drugs (tetracycline, Aspirin).To mention a few clinically recommended drugs in treatment of oral mucosal lesions are corticosteroids, cyclosporine, dapsone and group of interferon. The disastrous affect of thalidomide is well known to the human man kind (phocomalea), still this drug has proven to be quite affective in the treatment of resistant mucosal lesions.

The recent drugs which have been proven to be effective in treatment of pre malignant lesions and conditions (leukoplakia, oral sub mucous fibrosis) are lycopene, turmeric, pasteurized milk, caustic soda, aloe-Vera and topical application of bleomycin. [4]

Atypical oro facial pain is the most common complaint which is encountered by an oral physician, holistic medicine or complimentary medicine the gift blessed by our ancestors has been proven to be as effective as the allopathic medicine, (Ayurveda, Acupuncture, traditional Chinese medicine, humor therapy, dance therapy etc). Dry mouth is the common complaint often presented to the oral physician; the clinical trials conducted by North American health agencies recommend the use of topical fluoride for the treatment of xerostomia. [5] As stated by Gupta et al. cancer of the oral cavity is one of the five leading sites of cancer in India and squamous cell carcinoma comprises 80-85% of all malignancies, [6] the new clinical trials which are been carried out in the treatment of oral cancer are gene therapy, radio immuno therapy and stem cell therapy.

Dentistry today is on the high and is no more considered as an adjunctive care to the medical fraternity. As rightly said "Oral cavity is the mirror of systemic disease". It has to be remembered that manipulative care is no more accepted and there is no room for trial and error as we deal with human lives. All we need to do is to broaden our horizons and encourage the need and importance of clinical trials. In this sophisticated world of dentistry, we are no more helpless about the nature of the drug we give to our patients, as research today no more stands at the edge of a precipice see sawing between the known and the unknown. We are not staring in to a dark deep abbey, but instead we are walking on firm grounds illuminated by the light of evidence. It is high time that we extend our hands and join up to blend with what ought to be practiced today "The evidence-based dentistry" lets hope that the clinical trials do good to our patients so that we meet up the trust the patient has in us and let us join hands in "spreading the smile".


1Hoff TE. The rise of Early Modern Science. 2 nd ed. 2003. p. 56-7.
2Chow S-C and Liu JP.Design and analysis of clinical trials: Concepts and Methodologies. 2004
3Edinburgh, Churchill living stone, Pharmacology. 5 th ed. 2000.p. 16-7.
4Allen CM. Via dent-related leukoplakia-the tip of the ice berg? Oral Surg Oral Med Oral Pathol 1999;87:393-4.
5Shafer WG, Hine MK, Teri BN. A text book of Oral Pathology. 4 th ed. Philedaphia: WB Saunders; 1983. p. 269-70.
6Gupta PC, Mehta FS, Daftary DK, Pindborg JJ, Bhonsle RB, Jalnawalla PN, et al. Incidence rates of Oral cancer and natural history of Oral Pre cancerous lesion in a ten year follow up study of Indian Villagers. Community Dent Oral Epidemol 1980;8:283-90.